Risk Management Guide: Medical Device and Drug Safety Recalls

FDA uses the term "recall" when a manufacturer takes a corrective or removal action to address a problem with a medical device or drug that violates FDA regulations. Recalls occur when a medical device or drug is defective, when it could be a health risk, or when it is both defective and a health risk. Usually, the device or drug manufacturer recalls a device or drug independently. Accountability for medical device and drug safety recalls A person(s) should be appointed to lead all recall-related matters. This individual should subscribe to recall alerts and regularly monitor official channels, which can help healthcare organizations stay proactive in identifying and addressing recall issues. Monitor information on FDA recalls using…